Bulk pharmaceutical chemical validation

The focus of this chapter is bulk pharmaceutical chemical validation. Aside from the history section, the information presented to this point would apply to most any type of process. That commonality with other older validation efforts is deliberate. Bulk pharmaceutical chemical validation is unique, only to the extent that BPCs are unique. The underlying maxims of success for validation (the knowledge and understanding of the scientific basis upon which the equipment or process is based) are universal. Mastery of the overall approach equips one to effectively employ those concepts in a variety of settings. Some knowledge of the key concerns in the production of BPCs is essential to understanding how the validation of their preparation should be carried out. 

Berry, I.R. and Harpaz, D., Validation of Bulk Pharmaceutical Chemicals, Interpharm Press, Inc., Buffalo Grove, IL, 1997. 

Validation SOPs are written to provide explicit instruction on how to achieve the standards for those responsible for writing and executing master validation plans for drug, drug-device combinations, diagnostics, pharmaceutical biotechnology, and bulk pharmaceutical chemical products. Included is the ready-to-use template so that one can immediately save time and expense without missing any critical elements. 

PhARMA QC Section, Bulk Pharmaceuticals Committee. Concepts for the process validation of bulk pharmaceutical chemicals. Pharm Tech Eur 6(l) 37-42 (Jan. 1994). 

W.E. Hall, Validation of cleaning processes for bulk pharmaceutical chemical processes. Cleaning Validation—An Exclusive Publication, Institute of Validation Technology, 1997. 

This case study discusses the validation of Programmable Logic Controllers (PLCs) and the particular requirements within a bulk pharmaceutical chemical enviromnent. Emphasis is on bespoke systems, but the requirements of prebuilt PLC package systems are discussed in the section on embedded PLCs. 

PhRMA quality committee, bulk pharmaceuticals working group. PhRMA Guideline for the Validation of Cleaning Procedures for Bulk Pharmaceutical Chemicals. Pharm. Technol. 1997, 21 (9), 56-73. 

Process development equals process validation plus process optimization. A well-developed process is, therefore, by definition a well-validated process. Once it is decided that a bulk pharmaceutical chemical (BPC) process should be validated, the question becomes How In the case of a new process, the answer is simple Do a good process development job and document it (4). 

Process validation for a bulk pharmaceutical chemical (BPC) may include development data that describe the limitations and efficiency of the process. .. Their laboratory notebooks and their processing records also may be reviewed because these records may constitute the raw data for process validation (5). 

Sawyer, C. J. and Stats, R. W., Validation Requirements for Bulk Pharmaceutical Chemical Facilities, PAarw. Eng., pp. 44-52 (Sept.-Oct, 1992)... 

Validation was initially introduced in the 1970s to the pharmaceutical industry as a means for more firmly establishing the sterility of drug products where normal analytical methods are wholly inadequate for that purpose. In following years, its application was extended to numerous other aspects of pharmaceutical operations water systems, environmental control, tablet,and capsule formulations, analytical methods, and computerized systems. Individuals working with bulk pharmaceutical chemicals (BPCs) were particularly reluctant to embrace validation as a necessary practice in their operations. Industry apologists explained this lack of enthusiasm... 

Bulk pharmaceutical chemicals resemble other types of products validated in the pharmaceutical industry in that they utilize various in-process controls to support and monitor the process through its execution. Typical controls that might be a part of a BPC process include material specifications. 

Profile This privately held company was founded in 1972. It is a full-service drug synthesis and chemical services company that performs a variety of laboratory, process scale-up, and manufacturing tasks including development of processes and synthesis routes for new medicinal products, validating bulk pharmaceutical processes, and authoring Drug Master Files. The company also has a pilot plant/small volume manufacturing site in North Andover, Massachusetts. 

In the preface to the first edition of this book pubiished in 2000, we said Industrial applications of homogeneous catalysis are proven, and a much wider application in the future is anticipated. Growth in the area of homogeneous catalysis with transition metal over the last 12 years has been phenomenal, and the innumerable number of patent applications and successful commercialization of selected processes in sectors as diverse as bulk chemicals, specialty polymers, and pharmaceutical intermediates have validated our anticipation. 

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